Drug Fix: Lessons From US FDA Commissioner Nominee Heidi Overton’s Confirmation Hearing
Citeline PodcastsShow Notes
Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs dissect US Food and Drug Administration commissioner nominee Heidi Overton’s answers during her Senate confirmation hearing and dominant themes (:58), rate the potential for her confirmation (13:14), as well as consider her responses to particular controversial issues like mifepristone safety (16:06) and more practical issues like advisory committee meetings (21:23). They also look at the remaining hurdles for Overton’s bid to take control of the agency (24:40).
More On These Topics From The Pink Sheet
Overton Calls MMR Vaccine ‘Not Lethal,’ Defends Trump’s Claim As Outreach To Vaccine Skeptics: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/overton-calls-mmr-vaccine-not-lethal-defends-trumps-claim-as-outreach-to-vaccine-skeptics-TO3WNT3NUZGJ5IDRRUBDHF5CIA/
US FDA Commissioner Nominee Overton Says Adcomms ‘Critical,’ Hedges On Mifepristone Safety: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-nominee-overton-says-panels-are-critical-hedges-on-mifepristone-safety-RGSODPP5IRHLDA7A26TGOZ7LRI/
Former FDA Commissioners’ Backing May Help Overton Amid Stakeholder Opposition: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/former-fda-commissioners-backing-may-help-overton-amid-stakeholder-opposition-66MIFWT47ZDKDLYEFSBHMUEOEE/
More from Citeline Podcasts
Ahead of the awards presentation on Dec 2, the Scrip Awards podcast speaks to Mathai Mammen, CEO of Parabilis, one of the shortlisted companies for Biotech of The Year.
Disease-modifying Alzheimer’s treatments have arrived, but diagnosing the right patients at scale is still a major bottleneck. In this episode of Strategic Intent, Marion Webb (MedTech Insight) speaks with Dr. Soeren Mattke, research professor of economics at USC, director of the Brain Health Observatory, and member of the scientific advisory board of ALZpath, about how FDA-cleared blood tests are changing the picture.
In the latest episode of Off-Patent, On Record, Generics Bulletin’s senior reporter Urtė Fultinavičiūtė talks to the International Generic and Biosimilar medicines Association’s secretary general Ana Gaunt to mark the start of Global Biosimilars Week, a worldwide awareness and education campaign spotlighting the importance of biosimilars.
Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the reasons Iilun Murphy, director of the US Food and Drug Administration’s Office of Generic Drugs, decided to step down (:53) and whether the move should concern senior agency officials (2:51). They also consider the FDA’s plan to create a fit-for-purpose rare disease approval framework (12:19), how it will connect with the agency’s litany of programs for the products (14:52) and the potential difficulties of systematizing regulatory flexibility (18:22).
本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年10月9日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本周内容包括：中国带来的竞争威胁；第三季度并购活动降温；新型肺炎球菌疫苗竞争者；西班牙生物技术公司的战略；以及盐野义制药20亿美元的收购案。Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZCXOSRSNEBCARAW4DUWENVCPSQ/向听众们简要更新一下：Scrip现在已在Spotify和Apple Podcasts上开设了专属播客频道。Feedback: [email protected]